Consult Lhasa
Improving scientific risk assessments
globally, positively impacting human health.
How can we help?
Impurity formation
Potentially mutagenic impurities
Nitrosamines
Non-mutagenic impurities
Why choose Consult Lhasa?
Expert
scientific
consultants
Quality
assessments
In-depth knowledge of global regulations
Multi-lingual scientific consultants
“Our experience with Consult Lhasa has been very positive, resulting in a final report that we are confident will meet the scope required by regulatory agencies. The Consult Lhasa team are knowledgeable about the regulatory needs of the region, particularly Brazil, and provide great support. Their consulting has been invaluable to our company, the technical, scientific and human exchange has been impeccable. We are very satisfied with the collaboration.”
Adriana Tomalino, Head of Regulatory Affairs at Triquim

“We recently had the experience of collaborating with Consult Lhasa to address an EU regulatory deficiency on a potential degradation impurity of the drug substance. Consult Lhasa made an intriguing task look simple in the final report which was based on Zeneth, literature review and expert analysis. Their professionalism and commitment to excellence were truly commendable and their proactive approach made the entire process seamless and ensured that we met the stringent regulatory timelines. Their core scientific knowledge, hands-on experience with the pharmaceutical industry and caliber of their work make them a standout choice. It is evident that they take great pride in what they do, and this pride reflects in the exceptional quality of their work. We strongly recommend Consult Lhasa to anyone seeking expert advice on API degradation profile, drug-excipient compatibility, leachables & extractables, potentially mutagenic and non-mutagenic impurities and most importantly the nitrosamine impurities.”
Muzaffar Khan, Senior General Manager within Regulatory Affairs at Laurus Labs Limited

“We recently had the opportunity to collaborate with Consult Lhasa on the AI/ limit derivation of a new NDSRI. Given the challenge of limited specific data available for the queried nitrosamine, we sought Consult Lhasa’s expertise to enhance the robustness of our Read-Across approach. Their work is referenced in the latest global regulatory updates on nitrosamines, and this high level of scientific rigor was clearly reflected in their deliverables.
We sincerely thank the team for their deep scientific knowledge, timely efforts, and outstanding support.
We highly recommend Consult Lhasa and look forward to another productive collaboration in the future.”
Eleni Politi, Chemistry, Manufacturing and Controls/Safety Toxicologist at Rontis Hellas

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